EMEA-001851-PIP01-15 - paediatric investigation plan

Tiprelestat

Key facts

• Active Substance:
  Tiprelestat
• Therapeutic area:
  Oncology
• Decision number:
  P/0033/2016
• PIP number:
  EMEA-001851-PIP01-15
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of oesophageal carcinoma
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Proteo Biotech AG

  Germany; E-mail: [e-mail]; Tel.: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/01/2016

Decision

P/0033/2016: EMA decision of 29 January 2016 on the granting of a product specific waiver for tiprelestat (EMEA-001851-PIP01-15)

AdoptedReference Number: EMA/4263/2016